DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)— 510(k) K141385
Substantially EquivalentDepuy Synthes Companies of Johnson & Johnson
FDA 510(k) clearance K141385 for DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS), Substantially Equivalent on 2015-03-27. Applicant: Depuy Synthes Companies of Johnson & Johnson. Device class: 2.
Clearance details
- Applicant
- Depuy Synthes Companies of Johnson & Johnson
- Product code
- Code HBW
- Device class
- Class 2
- Regulation
- 21 CFR 882.5360
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Recent devices under product code HBW
view all- K251472 — Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
- K231208 — Stryker Resorbable Fixation System
- K171152 — Stryker Universal Neuro III System AXS Screw
- K151387 — Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
- K101835 — MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079
Recalls naming K141385
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141385.
Data sourced from openFDA. This site is unofficial and independent of the FDA.